P17.37 Safety and efficacy of elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate in treatment-naÏve japanese patients with hiv-1 infection

Introduction Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Disoproxil Fumarate (E/C/F/TDF), a single tablet regimen, is expected as a pillar of antiretroviral therapy. Although, there have been few reports on antiviral effects and adverse events in cases of its initial therapy among Asian patients. Methods We retrospectively reviewed medical records of patients treated with a single tablet regimen E/C/F/TDF once daily between May 2013 and October 2014. Patients with insufficient data and those with conditions such as chronic renal failure or viral hepatitis were excluded. Results In the 106 subjects who received E/C/F/TDF: 99% men, 31% viral load (VL) ≧100,000 copies/mL (c/mL). Median characteristics were: age 37 yrs, VL 4.85 log 10 c/mL, CD4 count 260 cells/μL. Mean change in CD4 count at Week 48 was +247 cells/μL, VL-2.7 log 10 c/mL. The serum creatinine level increased by 0.09 mg/dL: however, no further increase was seen during the observation period. There was no report of proximal renal tubulopathy including Fanconi Syndrome. Liver function tests and lipid markers demonstrated no significant changes. A total of 21 adverse events (AEs) were observed in 18 subjects (17.0%). The most common AEs were neurologic symptoms (dizziness, headaches, vivid dreams etc.), which occurred in 12 subjects: although, the symptoms either disappeared or ameliorated within 4 weeks in all subjects. No single AE led to discontinuation of more than 1 subject showed renal dysfunction. Virologic failure with resistance occurred in 3.8%. Conclusion High virologic response was seen in patients receiving E/C/F/TDF. This regimen was well tolerated, and no unique AEs were occurred, compared to the previous reports. These data support the use of E/C/F/TDF as a potential new regimen for initial treatment of Japanese patients with HIV-1 infection. Disclosure of interest statement Authors do not have any commercial or other association that might pose a conflict of interest.